The right healthcare regulatory compliance software can help organizations in the healthcare industry maintain compliance, mitigate risk, improve their finances and more – even amidst constantly changing requirements and protocols. Here’s everything you need to know about regulatory compliance, compliance software and key features to look out for.  

In this blog, we will answer the questions:  

  • What is regulatory compliance in healthcare?
  • What are compliance issues in healthcare?  
  • What are the basics of healthcare compliance software?  
  • What are key features of regulatory compliance software?  
  • What are the benefits of healthcare compliance software?  
  • What kind of organizations can benefit from regulatory compliance software?  


What is Regulatory Compliance in Healthcare?  

Regulatory compliance in healthcare is all about the various laws, guidelines, regulations and rules that organizations must adhere to in order to maintain clinical standards and ensure continued patient safety and quality of care over time. These regulations are usually set by the Department of Health and Human Services (HHS) Office of Inspector General (OIG).  

There are many areas that are covered by regulatory compliance regulations in healthcare, including:  

  • Patient care  
  • Billing  
  • OSHA  
  • Joint Commission on Accreditation of Healthcare Organizations  
  • HIPPA privacy and security rules  
  • Reimbursement  
  • COVID-19 readiness  

The goals? To protect healthcare programs from fraud or abuse, to protect confidential patient information and to keep patients safe. And this is nothing new. Healthcare regulations have been in place since the early 1900s – yet they have become more complicated over time.  

To meet compliance standards today, the OIG states that a compliance program must at least address:  

  • The development, distribution, and implementation of written standards of conduct and written policies and procedures that describe and further the organization's commitment to meeting and exceeding the legal and ethical standards applicable to the organization.
  • The designation of a chief compliance officer and other appropriate committees and individuals that are responsible for operating and monitoring the compliance program and who report directly to the organization's chief executive officer and the governing body.
  • The development and delivery of effective employee education and training programs
  • The development and maintenance of effective lines of communication that allow individuals to report compliance concerns without retaliation, including the ability to anonymously report concerns and complaints.
  • The development and implementation of a process to respond to complaints that include the imposition of appropriate corrective action including the discipline of employees when required.
  • The use of internal monitoring and audits to measure compliance and address known deficiencies.
  • Responding appropriately and quickly to detected offenses and implementing corrective action.


What Are Compliance Issues in Healthcare?  

Getting compliance right today is complicated. Organizations must not only keep up with frequently changing regulations but also understand which regulations apply to them and exceed all applicable legal, ethical and professional standards. What’s more, they must prove their ongoing compliance through documentation.  

That’s why many organizations use a healthcare compliance software to develop, implement and update their compliance programs.  


Healthcare Compliance Software: The Basics  

Healthcare compliance software can help ensure that healthcare organizations adhere to changing compliance standards and best practices. Overall, the right software can help organizations:  

  • Maintain compliance.
  • Decrease costs and resources associated with maintaining compliance.  
  • Avoid compliance violation fines.  
  • Effectively train employees to maintain compliance.  
  • Reduce fraud and abuse.  
  • Optimize their healthcare operations.  
  • Improve the delivery and quality of healthcare services.  


Features of Healthcare Compliance Software  

The right healthcare regulatory compliance software will help organizations:  

  • Keep track of changing compliance regulations and best practices.  
  • Develop procedures, best practices and standards of conduct that facilitate compliance.  
  • Easily identify and remedy compliance offenses.  
  • Execute internal monitoring and auditing measures.  
  • Execute effective compliance training and education.
  • Decrease the number of non-compliance issues.  

This can be accomplished through features like:  

Controlled Automated Workflows

When a user wants to make a change to a controlled document or submit it for review in a regulatory compliance software system, they initiate a controlled workflow to make that change. This forces documents to move through a defined workflow, which can prevent duplicate documentation and help ensure that all important steps are followed.  

Automated Audit Tracking  

A clear and accurate audit trail makes the entire auditing process easy and intuitive, helping organizations:  

  • Seamlessly connect your department stakeholders
  • Provide global and immediate access to business-critical documents  
  • Ensure compliance to Change Management standards  
  • Enhance efficiency by providing integrations with EAM, ERP, ECM, CAD systems, etc.  
  • Reduce risk and cost in data handover process between external contractors and internal stakeholders.

Risk Assessment  

Ongoing risk assessment and change management can help ensure that your systems and processes never fall out of compliance.

Real-Time Notifications

Real-time notifications can help users stay up to date with compliance activities and quickly respond to any issues.  

Contract Management

With real-time dashboards, users can define and assign contract reviews, schedule alerts based on key dates, check the status of policies and contracts, and more.  


Electronic signatures can help with document management. They can also facilitate compliance with key regulations like CFR 21 part 11.  


Benefits of Healthcare Compliance Software  

If you find the right healthcare compliance software for your business, you will be able to:  

  • Keep your organization up to date when it comes to changing compliance regulations and best practices.  
  • Develop procedures, best practices and standards of conduct that facilitate compliance.  
  • Easily identify and remedy compliance offenses.  
  • Execute internal monitoring and auditing measures.  
  • Execute effective compliance training and education.
  • Decrease the number of non-compliance issues.
  • Be prepared for audits related to existing compliance practices.  


What Kind of Organization Can Benefit from Healthcare Compliance Software?  

Organizations that can benefit from healthcare compliance software include:  

  • Hospitals
  • Clinics and outpatient care centers
  • Nursing, residential and long-term care facilities
  • Non-profit healthcare groups  

A similar software can also help organizations in Life Science industries maintain compliance and manage their documents. Learn more.